COBAS PRO

Description of Event or Problem

FDA EVENT REPORT ¿ FALSE ELEVATED TROPONIN RESULTS INVESTIGATION EVENT DATE: 06/29/2026 DEVICE: ROCHE COBAS E801 ANALYZER MODULE REPORT TYPE: POTENTIAL MEDICAL DEVICE MALFUNCTION RESULTING IN ERRONEOUS PATIENT RESULTS EXECUTIVE SUMMARY (B)(6) LABORATORY IDENTIFIED FALSELY ELEVATED TROPONIN RESULTS ASSOCIATED WITH TESTING PERFORMED ON A ROCHE E801 ANALYZER MODULE. NINE AFFECTED PATIENT EVENTS WERE DOCUMENTED THROUGH SAFER REPORTS. THE ISSUE WAS RECOGNIZED AFTER AN EMERGENCY DEPARTMENT PHYSICIAN REPORTED INCONSISTENT TROPONIN RESULTS AMONG MULTIPLE PATIENTS. INVESTIGATION OF ANALYZER LOGS REVEALED MULTIPLE ANALYZER ALARM CONDITIONS DURING THE TESTING PERIOD. DESPITE THESE ALARMS, THE ANALYZER CONTINUED PROCESSING PATIENT SAMPLES. REPEAT TESTING ON AN ALTERNATE ANALYZER DEMONSTRATED THAT SEVERAL INITIALLY REPORTED ELEVATED TROPONIN RESULTS WERE ERRONEOUS. EVENT TIMELINE (B)(6) 2026 TIME EVENT 20:58 REAGENT PROBE ALARM AND SAMPLE ALARM ASSOCIATED WITH RESERVOIR 1 AND 2 21:30 ADDITIONAL ANALYZER ALARM RESERVOIR 1 AND 2 21:52 ADDITIONAL ANALYZER ALARM RESERVOIR 1 AND 2 22:23 ADDITIONAL ANALYZER ALARM RESERVOIR 1 AND 2 DESCRIPTION OF EVENT FOLLOWING NOTIFICATION FROM CLINICAL STAFF, THE LABORATORY CONDUCTED AN INVESTIGATION. REVIEW OF ANALYZER LOGS IDENTIFIED MULTIPLE ALARMS DURING THE AFFECTED TESTING PERIOD. THE ANALYZER CONTINUED PROCESSING PATIENT SAMPLES DESPITE THE ALARM CONDITIONS. SUBSEQUENT REPEAT TESTING ON AN ALTERNATE ANALYZER CONFIRMED THAT SEVERAL REPORTED ELEVATED TROPONIN RESULTS WERE INACCURATE. THE ERRONEOUS RESULTS WERE CORRECTED, AND REVISED RESULTS WERE COMMUNICATED TO PROVIDERS AND NURSING STAFF. PATIENT IMPACT NINE SAFER REPORTS WERE COMPLETED FOR AFFECTED PATIENTS. THE FULL CLINICAL IMPACT ASSESSMENT REMAINS UNDER INVESTIGATION. PROVIDERS WERE NOTIFIED PROMPTLY AND CORRECTED LABORATORY RESULTS WERE ISSUED. ACTIONS TAKEN IDENTIFIED AND REVIEWED AFFECTED PATIENT RESULTS. PERFORMED REPEAT TESTING ON AN ALTERNATE ANALYZER. CORRECTED ERRONEOUS RESULTS IN THE MEDICAL RECORD. NOTIFIED PROVIDERS AND NURSING STAFF. COMPLETED EIGHT SAFER REPORTS. SUBMITTED FDA NOTIFICATION. ESCALATED THE ISSUE TO ROCHE TECHNICAL SUPPORT. INVESTIGATION STATUS 6/30/2026 THE INVESTIGATION REMAINS ACTIVE. ROCHE TECHNICAL SUPPORT HAS BEEN ENGAGED. THE LABORATORY IS AWAITING THE MANUFACTURER'S ROOT CAUSE ANALYSIS REGARDING THE RESERVOIR 1 AND 2 ALARM CONDITION, REAGENT PROBE AND SAMPLE ALARMS, ANALYZER BEHAVIOR DURING ALARM CONDITIONS, AND POTENTIAL IMPACT ON PATIENT TESTING. MULTIDISCIPLINARY CLINICAL REVIEW MEETING A MULTIDISCIPLINARY REVIEW MEETING WAS CONDUCTED ON 06/30/2026 AT 12:30 PM WITH PHYSICIANS, REGISTERED NURSES, AND THE RISK MANAGEMENT TEAM. THE GROUP REVIEWED THE LIST OF AFFECTED PATIENTS AND WAS ABLE TO COMPLETE REVIEW OF ALL IDENTIFIED CASES. NO PATIENT COMPLICATIONS RELATED TO THE ERRONEOUS TROPONIN RESULTS WERE IDENTIFIED DURING THE REVIEW. HOWEVER, THE TEAM EXPRESSED CONCERN REGARDING TWO POSSIBLE UNNECESSARY ADMISSIONS THAT MAY HAVE RESULTED FROM THE INACCURATE TROPONIN VALUES. DR. (B)(6) WILL PERFORM A DETAILED REVIEW OF THE MEDICAL RECORDS TO DETERMINE WHETHER THESE ADMISSIONS WERE DIRECTLY RELATED TO THE ERRONEOUS LABORATORY RESULTS AND TO ASSESS ANY ADDITIONAL PATIENT IMPACT. PLANNED CORRECTIVE AND PREVENTIVE ACTIONS OBTAIN AND REVIEW ROCHE FINAL INVESTIGATION REPORT. DETERMINE WHETHER ADDITIONAL PATIENTS MAY HAVE BEEN AFFECTED. REVIEW ANALYZER ALARM MANAGEMENT AND ESCALATION PROCESSES. EVALUATE ADDITIONAL STAFF EDUCATION REQUIREMENTS. ASSESS ENHANCED QUALITY CONTROL, MAINTENANCE, OR VERIFICATION PROCEDURES.